AirSep MN165-1 G User Manual

Page 27

[Read the Important Safety Rules section before operating this equipment.]

MN165-1 Rev G

8.0 Conformity with EN 60-601 (

§ 6.8.2 b) / Classification:

“

The manufacturer, assembler, installer or importer are not considered to be responsible themselves for the

consequences on the safety, reliability and characteristics of a device unless:

- The assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons
authorized by the party in question,

- The electrical installation of the corresponding premises complies with IEC regulations.

- The device is used in accordance with the instructions for use. “If the replacement parts used for the
periodic servicing by an approved technician do not comply with the manufacturer’s specifications, the
latter is absolved from all responsibility in the event of an accident. Do not open the device while in
operation: risk of electrical shock. This device complies with the requirements of the
MDD(93/42/EEC:2007/47/EC) Annex I European directive but its operation may be affected by other
devices being used close by, such as diathermy and high frequency electro-surgical equipment,
defibrillators, short wave therapy equipment, mobile telephones, CB and other portable devices, microwave
ovens, induction plates or even remote control toys and more generally electromagnetic interferences which
exceed the levels specified by the EN 60601-1-2 standard.

Classification

Type of protection against electric shock:

Class II

Protection from electric shock is achieved by DOUBLE INSULATION.

Protective earthing or reliance upon installation conditions are not required.

Degree of protection against electric shock:
Type B

Equipment providing a particular degree of protection against electric shock, particularly
regarding:

1) Allowable leakage current;

2) Reliability of protective earth connection (if present).

Not intended for direct cardiac application.

Method of cleaning and infection control allowed:

Please refer to your Equipment Provider and the VisionAire Service Manual.

Degree of safety of application in the presence of flammable gases:

Equipment not suitable for such application.

Mode of operation: Continuous duty.

For European Representative:

Gavin Ayling
9 Bungham Lane
Penkridge Stafford

Staffordshire ST19 5NH England

E-mail: [email protected]